510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K011416Substantially Equivalent

Muscle Imaging System (Mis)

Millennium Magnetic Imaging, Inc., Hoover AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011416 is the FDA 510(k) clearance record for MUSCLE IMAGING SYSTEM (MIS), a class II device, cleared for Millennium Magnetic Imaging, Inc. on under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging). FDA records list one 510(k) clearance for Millennium Magnetic Imaging, Inc. As of , FDA records show no recalls naming K011416.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LNH System, Nuclear Magnetic Resonance Imaging
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Millennium Magnetic Imaging, Inc. 210 Lorna Sq., Pmb 192, Hoover AL
510(k) summary
Statement
Third party review
No

Clearances, product code LNH

Trailing 12 months
28 clearances under product code LNH in the twelve months to October 2026, March 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code LNH, trailing twelve months
MonthClearances
November 20251
December 20253
January 20261
February 20264
March 20266
April 20261
May 20261
June 20260
July 20262
August 20263
September 20263
October 20263